前白蛋白檢測試劑盒（免疫比濁法）

滬械注準(zhǔn)20172400247

上海市閔行區(qū)三魯公路3279號1幢1號樓3層、4層

2022-03-31

2027-03-30

R1：三羥甲基氨基甲烷（Tris）、聚乙二醇6000、NaCl、Proclin 300；R2：三羥甲基氨基甲烷（Tris）、羊抗人PA抗體、NaCl、Proclin 300；校準(zhǔn)品：Tris緩沖液、甘油、PA抗原、Proclin300

供醫(yī)療機構(gòu)用于體外定量檢測人血清或血漿樣本中的前白蛋白的含量，作輔助診斷用。

注冊人住所、生產(chǎn)地址由“上海市閔行區(qū)聯(lián)航路1588號1幢軟件孵化大樓1#樓301、302室”變更為“上海市閔行區(qū)三魯公路3279號1幢1號樓3層、4層”。;本文件與“滬械注準(zhǔn)20172400247”注冊證共同使用。;2017-09-05

上海市閔行區(qū)三魯公路3279號1幢1號樓3層、4層

1) R1:1×20ml、R2:1×7ml\\n2) R1:1×45ml、R2:1×15ml\\n3) R1:3×45ml、R2:3×15ml\\n4) R1:1×60ml、R2:1×20ml\\n5) R1:2×90ml、R2:4×15ml\\n6) R1:3×60ml、R2:3×20ml\\n7) R1:10×60ml、R2:10×20ml\\n8) R1:3×80ml、R2:4×20ml\\n9) R1:4×450ml、R2:4×150ml\\n10) R1:2×300ml、R2:2×100ml\\n11) R1:3×45ml、R2:1×45ml\\n12) 西門子測試數(shù):1700測試\\/盒\(zhòng)\n13) R1:1×20ml、R2:1×7ml、校準(zhǔn)品:4×0.5ml\\n14) R1:1×45ml、R2:1×15ml、校準(zhǔn)品:4×0.5ml\\n15) R1:3×45ml、R2:3×15ml、校準(zhǔn)品:4×0.5ml\\n16) R1:1×60ml、R2:1×20ml、校準(zhǔn)品:4×0.5ml\\n17) R1:2×90ml、R2:4×15ml、校準(zhǔn)品:4×0.5ml\\n18) R1:3×60ml、R2:3×20ml、校準(zhǔn)品:4×0.5ml\\n19) R1:10×60ml、R2:10×20ml、校準(zhǔn)品:4×0.5ml\\n20) R1:3×80ml、R2:4×20ml、校準(zhǔn)品:4×0.5ml\\n21) R1:4×450ml、R2:4×150ml、校準(zhǔn)品:4×0.5ml\\n22) R1:2×300ml、R2:2×100ml、校準(zhǔn)品:4×0.5ml\\n23) R1:3×45ml、R2:1×45ml、校準(zhǔn)品:4×0.5ml\\n24) 西門子測試數(shù):1700測試\\/盒、校準(zhǔn)品:4×0.5ml

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第二類